Prescription drug · ANDA
Zolpidem Tartrate NDC 80425-0513
Zolpidem tartrate 5 mg/1 · Tablet, Coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0513-1 | 80425051301 | 30 TABLET, COATED in 1 BOTTLE (80425-0513-1)Marketed from Apr 15, 2025 | |
| 80425-0513-2 | 80425051302 | 60 TABLET, COATED in 1 BOTTLE (80425-0513-2)Marketed from Apr 15, 2025 | |
| 80425-0513-3 | 80425051303 | 90 TABLET, COATED in 1 BOTTLE (80425-0513-3)Marketed from Apr 15, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zolpidem Tartrate
- Generic name (nonproprietary)
- zolpidem tartrate
- Active ingredients
- Zolpidem tartrate — 5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077322
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
- Identifiers
- Product ID 80425-0513_3310d645-9b5f-16f5-e063-6294a90a9eb5SPL ID 3310d645-9b5f-16f5-e063-6294a90a9eb5SPL set ID 3310d63e-d79a-175d-e063-6394a90a4270RxCUI 854876UNII WY6W63843K
- Pharmacologic class
- gamma-Aminobutyric Acid A Receptor Positive Modulator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425051301followed by a unit qualifier and the quantityPackage 80425-0513-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14 )]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077322
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-3739 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 63187-690 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 63187-691 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, CoatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-761 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8854 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-9629 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 82868-078 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, CoatedOral | Advanced Rx of Tennessee, LLC | 80425-0060 |
| Zolpidem Tartrate | Zolpidem tartrate 5 mg/1 | Tablet, CoatedOral | Sandoz Inc | 0781-5317 |
| Zolpidem Tartrate | Zolpidem tartrate 10 mg/1 | Tablet, CoatedOral | Sandoz Inc | 0781-5318 |